September 27, 2010 – A post-market study investigating a new treatment for peripheral artery disease of the superficial femoral artery (SFA) has completed enrollment.
The VIPER study, which is looking at the performance of the Gore Viabahn endoprosthesis with a heparin bioactive surface, enrolled 120 patients.
Forty patients were treated with the endoprosthesis with heparin bioactive surface alone, while the remaining 80 were treated with the endoprosthesis with heparin bioactive surface manufactured with the proximal contoured edge. The contoured edge resulted from a manufacturing process change and may improve flow dynamics at the inlet of the device in conditions of over-sizing.
“Speaking for the Gore VIPER investigators, we are pleased to have completed enrollment and are enthusiastic about determining the results,” said Richard Saxon, M.D., FSIR, director of research for the San Diego Cardiac and Vascular Institute and North County Radiology Medical Group in Oceanside, Calif., and principal investigator for the study. “SFA studies like Gore VIPER help us to determine the best endovascular treatment options for our patients suffering from atherosclerotic occlusive disease. Although many studies fail to include longer lesions, average lesion length treated in the Gore VIPER Study was approximately 18 centimeters, so we are definitely capturing a challenging, real-world experience. Moreover, having both patients with the Gore Viabahn endoprosthesis with heparin bioactive surface alone as well as patients treated with the Gore Viabahn endoprosthesis with heparin bioactive surface manufactured with the proximal contoured edge will hopefully give us some insight into the clinical impact of the contoured edge device.”
Arun Chervu, M.D., of Wellstar Cobb Hospital, Atlanta, and a leading enroller in the VIPER Study, said, “The intent of the study was to initiate a post-market evaluation of Gore Viabahn endoprosthesis with heparin bioactive surface in the treatment of long SFA disease. Our center has used the device to cover lesions up to 40 centimeters in length and we look forward to understanding how the device performs in these challenging clinical circumstances.”
The Gore Viabahn endoprosthesis was originally approved for treating SFA obstructive disease in the United States in 2005. The VIPER study comprises the first multicenter evaluation of the Gore Viabahn endoprosthesis with heparin bioactive surface, which was introduced in the United States in 2007.
For more information: www.goremedical.com